Trial Condition(s):

Vasomotor symptoms associated with menopause, Hot Flashes

A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 26 weeks in women who have been through the menopause (OASIS-2)

Bayer Identifier:

21652

ClinicalTrials.gov Identifier:

NCT05099159

EudraCT Number:

2020-004855-34

EU CT Number:

Not Available

Recruitment Complete

Trial Purpose

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman’s body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.
The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people.
In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants’ hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment.
The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks.
During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks.
During the study, the participants will:
•    record information about the participants’ hot flashes in an electronic diary
•    answer questions about the participants’ symptoms
The doctors will:
•    check the participants’ health
•    take blood samples
•    ask the participants questions about what medicines the participants are taking and if the participants are having adverse events
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

Inclusion Criteria
- Postmenopausal, defined as:
       a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
       b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
       c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
       d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
  - Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
  - Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).
Exclusion Criteria
- Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
  - Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
  - Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.
  - Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.
  - Untreated hyperthyroidism or hypothyroidism. 
• Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable.
• Treated hypothyroidism with normal thyroid function test results during screening and a stable (for ≥ 3 months before signing of informed consent) dose of replacement therapy is acceptable.
  - Any unexplained post-menopausal uterine bleeding.
  - Clinically relevant abnormal findings on mammogram.
  - Abnormal liver parameters.
  - Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.

Trial Summary

Enrollment Goal
400
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Elinzanetant (BAY3427080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Dr. S. Fiedler

Aachen, Germany, 52074

Status
Completed
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Active, not recruiting
Locations

Femme Frauenarztpraxis

Gera, Germany, 07545

Status
Active, not recruiting
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Active, not recruiting
Locations

Frauenarztpraxis Dr. Inka Kiesche

Halle, Germany, 06110

Status
Active, not recruiting
Locations

Frauenärzte am Schloss Borbeck

Essen, Germany, 45355

Status
Active, not recruiting
Locations

Helix Biomedics, LLC

Boynton Beach, United States, 33435

Status
Recruiting
Locations

Suncoast Clinical Research Center, Inc.

New Port Richey, United States, 34652

Status
Recruiting
Locations

Advances in Health, Inc.

Houston, United States, 77030

Status
Recruiting
Locations

Ocean Blue Medical Research Center, Inc.

Miami Springs, United States, 33166

Status
Recruiting
Locations

Memphis Obstetrics and Gynecological Association, PC

Memphis, United States, 38120

Status
Recruiting
Locations

Unified Women's Clinical Research - Raleigh

Raleigh, United States, 27607

Status
Recruiting
Locations

Oregon Health and Science Univ | OHSU OBGYN-Women's Hlth Res

Portland, United States, 97239

Status
Recruiting
Locations

Lawrence OB/GYN Associates

Lawrenceville, United States, 08648

Status
Completed
Locations

Clinical Research of West Florida, Inc.

Clearwater, United States, 33765

Status
Recruiting
Locations

Medical Research Center of Memphis, LLC

Memphis, United States, 38120

Status
Recruiting
Locations

Accel Research Sites - Cahaba Medical Care

Birmingham, United States, 35218

Status
Recruiting
Locations

Sweet Hope Research Specialty, Inc. - Miami Lakes

Hialeah, United States, 33016

Status
Recruiting
Locations

Columbia University Medical Center

New York, United States, 10032

Status
Recruiting
Locations

Advanced Women's Health Institute

Greenwood Village, United States, 80111

Status
Recruiting
Locations

Signature GYN Services, Pllc

Fort Worth, United States, 76104-4145

Status
Recruiting
Locations

Clinical Research of West Florida, Inc - Clearwater

Clearwater, United States, 33603

Status
Recruiting
Locations

Affinity Healthcare, LLC

Oak Brook, United States, 60523

Status
Recruiting
Locations

Fellows Research Alliance - Savannah

Savannah, United States, 31406

Status
Recruiting
Locations

University of Virginia Midlife Health Center

Charlottesville, United States, 22903

Status
Recruiting
Locations

Kantonsspital Baden

Baden, Switzerland, 5404

Status
Completed
Locations

Tribe Clinical Research

Greenville, United States, 29607

Status
Completed
Locations

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, Poland, 15-244

Status
Recruiting
Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Status
Recruiting
Locations

Centrum Medyczne Angelius Provita

Katowice, Poland, 40-611

Status
Recruiting
Locations

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

Status
Recruiting
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Status
Recruiting
Locations

GA Lucenec s.r.o

Lucenec, Slovakia, 984 01

Status
Active, not recruiting
Locations

GYNARIN, s.r.o.

Filakovo, Slovakia, 986 01

Status
Active, not recruiting
Locations

ULMUS, s r.o.    

Hlohovec, Slovakia, 920 01

Status
Active, not recruiting
Locations

Clinique OVO

Montreal, Canada, H4P 2S4

Status
Recruiting
Locations

Alpha Recherche Clinique LB9

Quebec, Canada, G2J 0C4

Status
Recruiting
Locations

ALPHA Recherche Clinique

Val-Bélair, Canada, G3K 2P8

Status
Completed
Locations

Alta Clinical Research

Edmonton, Canada, T5A 4L8

Status
Recruiting
Locations

Kirkeparken Spesialistpraksis

Fredrikstad, Norway, 1605

Status
Active, not recruiting
Locations

OUS Ullevål Gynecology Department

Oslo, Norway, 0450

Status
Active, not recruiting
Locations

Medicus AS

Trondheim, Norway, 7014

Status
Active, not recruiting
Locations

Clinical Trials Management, LLC - Covington

Covington, United States, 70433

Status
Recruiting
Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

Status
Active, not recruiting
Locations

Saginaw Valley Medical Research Group, LLC

Saginaw, United States, 48604

Status
Recruiting
Locations

CHUC - Hospitais da U. Coimbra - Servico de Ginecologia

Coimbra, Portugal, 3004-561

Status
Completed
Locations

CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

Lisboa, Portugal, 1649-035

Status
Completed
Locations

Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

Lisboa, Portugal, 1449-005

Status
Completed
Locations

Hospital da Luz - Setubal

Setubal, Portugal, 2900-722

Status
Completed
Locations

Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Loures, Portugal, 2674-514

Status
Active, not recruiting
Locations

ULSM - Hospital Pedro Hispano

Matosinhos, Portugal, 4464-513

Status
Active, not recruiting
Locations

DiscoveResearch, Inc.

Bryan, United States, 77802

Status
Recruiting
Locations

Family Care Research

Boise, United States, 83713

Status
Recruiting
Locations

Diex Recherche Victoriaville Inc.

Victoriaville, Canada, G6P 6P6

Status
Recruiting
Locations

UniversitätsSpital Zürich

Zürich, Switzerland, 8091

Status
Terminated
Locations

Medicus Stavanger AS

Stavanger, Norway, 4005

Status
Active, not recruiting
Locations

Medicus Oslo AS

Oslo, Norway, 0161

Status
Active, not recruiting
Locations

Womens Health Care Research Corporation

San Diego, United States, 92111

Status
Recruiting
Locations

Austin Regional Clinic

Pflugerville, United States, 78660

Status
Recruiting
Locations

Clinical Trials Research

Lincoln, United States, 95648

Status
Recruiting
Locations

Eastern Carolina Women's Center

New Bern, United States, 28562

Status
Recruiting
Locations

Torrance Clinical Research- Lomita

Lomita, United States, 90717

Status
Recruiting
Locations

Physicians' Research Options, LLC

Draper, United States, 84020

Status
Not yet recruiting
Locations

Metro Jackson OB-GYN

Jackson, United States, 39202

Status
Recruiting
Locations

Physicians Research Options, LLC

Lakewood, United States, 80228

Status
Recruiting
Locations

Leavitt Clinical Research

Idaho Falls, United States, 83404

Status
Recruiting
Locations

Tandem Clinical Research

Marrero, United States, 70072

Status
Recruiting
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Active, not recruiting
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Active, not recruiting
Locations

A.O. Ordine Mauriziano

Torino, Italy, 10128

Status
Active, not recruiting
Locations

A.O.U. Policlinico Federico II Napoli

Napoli, Italy, 80131

Status
Active, not recruiting
Locations

Medplus Nordrhein

Krefeld, Germany, 47799

Status
Completed
Locations

Gynekologie Studentsky dum s.r.o.

Praha 6, Czech Republic, 160 00

Status
Active, not recruiting
Locations

GYNEVI s.r.o.

Rokycany, Czech Republic, 337 01

Status
Active, not recruiting
Locations

GynPorCentrum s.r.o.

Krnov, Czech Republic, 794 01

Status
Active, not recruiting
Locations

Gynpraxetabor s.r.o.

Tabor, Czech Republic, 39003

Status
Active, not recruiting
Locations

Synexus Frankfurt Clinical Research Centre

Frankfurt, Germany, 60313

Status
Active, not recruiting
Locations

MUDr. Martina Maresova Rosenbergova, gynekologie

Plzen, Czech Republic, 300 01

Status
Active, not recruiting
Locations

Synexus Leipzig Clinical Research Centre

Leipzig, Germany, 04103

Status
Completed
Locations

CHUP - Servico de Investigacao Clinica

Porto, Portugal, 4050-651

Status
Completed
Locations

Synexus Clinical Research GmbH

Berlin, Germany, 12627

Status
Active, not recruiting
Locations

Etyka Osrodek Badan Klinicznych

Olsztyn, Poland, 10-117

Status
Recruiting
Locations

Ob and Gyn Physicians MidAtlantic - SKYCRNG

Oxon Hill, United States, 20705

Status
Recruiting
Locations

Sensible Healthcare, LLC

Ocoee, United States, 34761

Status
Recruiting
Locations

ClinRx Research, LLC

Plano, United States, 75024

Status
Recruiting
Locations

South Texas Clinical Research

Corpus Christi, United States, 78413

Status
Recruiting
Locations

Onyx Clinical Research - Peoria

Peoria, United States, 85381

Status
Recruiting
Locations

Ecogene21

Chicoutimi, Canada, G7H 0S7

Status
Recruiting
Locations

Women's Health Alliance of Mobile

Mobile, United States, 36604

Status
Recruiting
Locations

Diex Recherche Quebec Inc.

Quebec, Canada, G1V 4T3

Status
Recruiting
Locations

Diex Recherche Sherbrooke Inc.

Sherbrooke, Canada, J1L 0H8

Status
Recruiting
Locations

Recherche GCP Research

Montreal, Canada, H1M 1B1

Status
Recruiting
Locations

UT Health Women’s Research Center at Memorial City

Houston, United States, 77024

Status
Recruiting
Locations

National Institute of Clinical Research - Garden Grove

Garden Grove, United States, 92844

Status
Recruiting
Locations

Nemocnica AGEL Kocice-Saca a.s.

Kosice - Saca, Slovakia, 040 15

Status
Active, not recruiting
Locations

Tidewater Clinical Research, Inc.

Norfolk, United States, 23456

Status
Recruiting

Trial Design